FDA.report

RUSCH

Primary DI
44026704053702
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN052287
Catalog number
403340-000140
Device description
Bladder catheter, Robinson, 2 eyes
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KODCATHETER, UROLOGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
KODCatheter, UrologicalGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
14026704053701Direct MarkingGS10
24026704053708PackageGS110In Commercial Distribution
44026704053702PackageGS142In Commercial Distribution
04026704053704PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1402670405370114026704053701
2402670405370824026704053708
4402670405370244026704053702
04026704053704040267040537044026704053704

GMDN Terms

TermDefinition
Intermittent urethral drainage catheter, reusableA flexible or rigid tube designed to be repeatedly inserted through the urethra, typically by the user (i.e., self-applied), to the urinary bladder to provide short-term, episodic urine drainage (removed after each void), typically for an individual who is physiologically incapable of voiding. Because of the potential frequency of catheterization, the device will typically be pre-lubricated or coated with/made of materials that facilitate easy insertion and removal [e.g., polytetrafluoroethylene (PTFT) - Teflon, or glass]. The device may be male or female dedicated. This is a reusable device.

Device Sizes

TypeValueUnit
Catheter Gauge14French

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags

DUNS number
002348191
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
true

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